Newsletter – March 2015   Trimethoprim  -­‐  Sulfamethoxazole  Combined  with   ACE  Inhibitors  or  Angiotensin  II  Receptor  Blockers   Could  Raise  Risk  of  Sudden  Death  in  Elderly   Written  By:  Malyssa  West  –  ISU  Pharm  D  Candidate  2016  

Hyperkalemia,  defined  as  a  serum  potassium  level  above  5.5  mmol/L,   is  more  common  in  the  elderly,  and  can  be  fatal  when  severe.1      Signs   and  symptoms  associated  with  hyperkalemia  include  muscle   weakness,  fainting,  upset  stomach,  fatigue,  bradycardia  and   tachycardia.2  Commonly,  patients  may  lack  signs  and  symptoms  of   hyperkalemia  which  may  results  in  the  electrolyte  abnormality  only   being  discovered  though  laboratory  findings  or  electrocardiogram   (EKG).  2  Dangerous  adverse  effects  of  hyperkalemia  include  cardiac   arrhythmias,  torsades  de  pointes,  and  sudden  death.2  Therefore,  it   should  be  considered  a  serious  and  life-­‐threatening  condition  that   requires  immediate  treatment  or  implementation  of  preventative   measures  in  the  patient  care  setting.    

Idaho Drug Information Center Idaho State University 921 S. 8th Ave, Stop 8092 Pocatello, ID 83209-8092 208-282-4689 [email protected] Rebecca Hoover, PharmD, MBA, Director, [email protected] Location: Third floor Eli Oboler Library at ISU

Combining  potassium-­‐sparing  medications  can  lead  to  an  increased   risk  for  elderly  patients  to  develop  hyperkalemia  and  possibly   hyperkalemia-­‐induced  arrhythmias.3,4,5  Elderly  patients  are  already  at   a  higher  risk  for  developing  drug-­‐induced  hyperkalemia  due  to  an   age-­‐related  reduction  in  glomerular  filtration  rate  and  decreased   activity  of  the  renin-­‐angiotensin-­‐aldosterone  (RAA)  system.1    This   alone  could  lead  to  hyperkalemia,  however,  most  elderly  patients     diagnosed  are  on  drug  therapy  that  includes  a  combination  of   potassium-­‐sparing  medications.1       Two  very  common  medications  prescribed  today  are  angiotensin-­‐ converting-­‐enzyme  inhibitors  (ACEIs)  and  angiotensin  II  receptor   blockers  (ARBs).    Primarily  these  medications  are  used  for  the   treatment  of  hypertension,  coronary  artery  disease,  congestive  heart   failure,  and  chronic  kidney  disease  in  the  geriatric  population.3  Both   ACEIs  and  ARBs  are  potassium-­‐sparing  medications  and  can  induce   hyperkalemia,  with  elderly  patients  having  an  increased  risk  of   developing  this  particular  adverse  reaction.4,  5    

 

Newsletter – March 2015   The  combination  antibiotic  trimethoprim-­‐sulfamethoxazole  (TMP-­‐SMX)  is  frequently  prescribed  for   treatment  of  urinary  tract  infections  (UTIs),  which  are  commonly  seen  in  the  elderly.3,4,5       Trimethoprim  has  various  similarities  with  potassium-­‐sparing  diuretics  and,  likewise,  can  impair   renal  potassium  elimination.3,4    Therefore,  patients  taking  TMP-­‐SMX  develop  commonly  have   increases  of  serum  potassium.       As  mentioned  earlier,  severe  hyperkalemia  can   result  from  taking  multiple  potassium-­‐sparing   medications  at  the  same  time.    Because  TMP-­‐ SMX,  ACEIs,  and  ARBs  are  widely  used   medications  in  the  elderly,  the  chance  of  co-­‐ administration  is  extremely  high.    Independently,   these  commonly  prescribed  medications  will   only  have  a  modest  effect  on  potassium  levels.     However,  combination  may  result  in  life   threatening  hyperkalemia  which  is  often  further   exacerbated  by  comorbidities  seen  in   geriatrics.1,2    Population-­‐based  studies  have   found  that  the  use  of  TMP-­‐SMX  in  conjunction   with  ACEIs  or  ARBs  has  been  associated  with   nearly  a  7-­‐fold  increase  in  the  risk  of   hyperkalemia  when  compared  to  using   amoxicillin  in  place  of  TMP-­‐SMX.    Although  TMP-­‐ SMX  may  be  the  best  choice  for  the  UTI  infection,   an  alternative  antibiotic  might  be  a  better  choice   for  a  patient  taking  a  potassium-­‐sparing   medication.    In  practice,  TMP-­‐SMX  is  still  widely   prescribed  to  elderly  patients  who  are  taking   ACEs  or  ARBs.    Because  of  this,  sudden  death  in   the  elderly  can  be  mistaken  for  an  underlying   cardiovascular  disease,  rather  than  recognized  as   hyperkalemia-­‐induced  arrhythmias  associated   with  the  combination  of  TMP-­‐SMX  and  ACEIs  or  ARBs.3,4,5   Increased  awareness  of  this  drug  interaction  among  pharmacists  and  physicians  is  essential.    The   combination  of  the  potassium-­‐sparing  medications  like  TMP-­‐SMX,  ACEIs,  and  ARBs  should  be   limited.    Options  include  choosing  an  alternative  antibiotic  therapy  when  possible,  reducing  dose   and  duration  of  TMP-­‐SMX  treatment,  monitoring  for  abnormal  EKGs,  and  by  monitoring  serum   potassium  levels  of  elderly  patients  on  this  drug  combination.  3,4,5    

 

 

 

 

Newsletter - March 2015  

Hypnotics  and  Insomnia  Refresher    

Written  By:  Ryan  Jensen  –  ISU  Pharm  D  Candidate  2016    

Hypnotics  are  drugs  used  to  induce  sleep.    There  are  multiple   drug  classes  that  possess  the  ability  to  cause  hypnosis  either  as   a  secondary  or  primary  action.    These  include  antihistamines,   benzodiazepines,  non-­‐benzodiazepine  hypnotics,  melatonin   receptor  agonists,  antidepressants,  barbiturates,   anticonvulsants,  and  antipsychotics.1    The  following   information  below  is  a  summary  of  different  agents  and   approaches  for  the  treatment  of  insomnia.     General  pharmacological  stepwise  approach  for  the  treatment  of  insomnia  supported  by  the  American  A cademy  of   Sleep  Medicine  (AASM)1  

  Step  1 :  Short-­‐intermediate  acting  benzodiazepine  receptor  agonist  (BzRA)  or  ramelteon.  BzRA,  in  this  case,  is  either   a  classical  benzodiazepine  or  a  newer  non-­‐benzodiazepine  hypnotic.    The  non-­‐benzodiazepines  appear  to  have  less   side  effects,  dependence,  and  rebound  insomnia  than  classical  benzodiazepines2     Step  2 :  Use  an  alternate  BzRA  or  ramelteon  if  patient  fails  the  initial  treatment.       Step  3 :  A  sedating  antidepressant  may  be  considered  next  if  the  patient  suffers  comorbid  depression/anxiety  or  if   the  patient  fails  previous  treatments.       Step  4 :  Sedating  antiepileptic  or  antipsychotic  drugs  may  be  attempted  if  the  patient  has  a  comorbid  condition  that   benefits  from  the  primary  action  of  the  drug.         Not  recommended  for  chronic  insomnia:  OTC  antihistamines,  analgesics-­‐type  drugs,  herbs,  and  natural   supplements     Not  recommended  for  occasional  or  chronic  insomnia:  Barbiturates,  barbiturate-­‐like  drugs,  and  chloral  hydrate.      

   

  Non-­‐Benzodiazepine  hypnotics   • Used  for  the  onset  of  sleep  only   Zolpidem     (Ambien®)   • Short-­‐intermediate  acting2   Zolpidem  CR     (Ambien  CR®)   Zaleplon     (Sonata®)   Eszopiclone   (Lunesta®)  

 

• • • • • • • • •

10  mg  in  some  patients  has  risk  for  daytime  drowsiness2   Used  for  onset  and  maintenance  of  sleep   12.5  mg  in  some  patients  has  risk  for  daytime  drowsiness2   Used  for  onset  of  sleep  usually  (if  patient  awakes  during  sleep,  may  take   for  maintenance  if  >4  hours  of  sleep  time  remaining)2   Short  acting2   This  agent  can  be  used  long  term  without  restrictions   Used  for  maintenance  and  onset  of  sleep   Intermediate  acting2   Bad  aftertaste2,3  

 

Newsletter – March 2015   Benzodiazepines   Estazolam   (Prosom®)  

Flurazepam   Lorazepam   (Ativan®)  

Quazepam   (Doral®)  

Temazepam   (Restoril®)  

Triazolam   (Halcion®)  

    Antidepressants   Amitryptyline   Doxepin     (Silenor®)  

Mirtazapine   (Remeron®)  

Trazadone   (Oleptro®)  

     

• • • • • • • • • • • • • • • •

• • • • • • • • • • •

Used  for  maintenance  and  onset  of  sleep   Short-­‐intermediate  acting2   Avoid  with  CYP  3A4  inhibitors3   Used  for  maintenance  and  onset  of  sleep   Long  acting2   Higher  risk  for  daytime  drowsiness2   Off-­‐label  use  for  maintenance  of  sleep  only4   Used  for  secondary  insomnia  due  to  anxiety2,5   Long  acting2   Used  for  onset  and  maintenance  of  sleep   Used  for  onset  and  maintenance  of  sleep   Short-­‐intermediate  acting2   No  CYP450  interactions  and  considered  better  choice  for  elderly   patients2,3   Used  for  onset  of  sleep  only   Higher  incidence  of  rebound  insomnia,  not  considered  first  line   therapy1,2,3   Avoid  with  CYP  3A4  inhibitors  and  avoid  in  elderly2,3  

Off  label  use  for  comorbid  insomnia1   High  prevalence  of  anticholinergic  effects1   Use  caution  in  patients  with  risk  or  history  of  cardiac  disease   Used  for  maintenance  of  sleep  only   No  or  little  rebound  insomnia  or  dependence6   Take  3  hours  after  meal  to  avoid  delayed  absorption  and  next  day   drowsiness3   Off  label  use  for  comorbid  insomnia   Less  anticholinergic  effect  than  doxepin  and  amitriptyline2   Risk  of  restless  leg  syndrome  and  weight  gain1,6   Off  label  use   Less  anticholinergic  effect  than  doxepin  and  amitriptyline2  

Melatonin  Receptor  Agonist   • This  agent  can  be  used  long  term  without  restrictions1,3   Ramelteon   (Rozerem®)  

Tasimelteon     (Hetlioz®)  

       

• • • • • •

Used  for  the  onset  of  sleep  only   Short  acting   One  of  the  few  hypnotic  drugs  that  shows  no  dependence2,6   Recently  FDA  approved  for  non-­‐24-­‐hour  sleep-­‐wake  disorder4   Helps  reset  the  circadian  cycle  when  it  is  too  long   Specifically  for  blind  patients  who  have  hard  time  falling  and  staying   asleep  

 

 

 

 

Newsletter - March 2015   Other  hypnotic  Drugs   • OTC   antihistamines   • •

Barbiturates  

• •

 



Supplements   Antipsychotics  

• • • •

Anticonvulsants  

• • •

New  drug   target  

• • •

Agents  include  diphenhydramine  (Benadryl®),  doxylamine  (Unisom®),   and  dimenhydrinate  (Dramamine®)   Anticholinergic  effects7   Not  recommended  for  primary  insomnia  conditions.    If  used,  patients   should  be  counseled  to  have  an  “off”  night  every  3  nights  to  avoid   tolerance7,8   Maximum  use  should  be  no  more  than  2  weeks   Agents  include  butabarbital  (Butisol  Sodium®)  and  secobarbital   (Seconal®)2,4   Not  recommended  due  to  side  effect  profile,  addiction  tolerance,  and  low   therapeutic  index1,2   Agents  include  melatonin,  valerian,  L-­‐tryptophan   Mildly  sedative,  not  much  evidence1,8   Agents  include  clonazapine,  quetiapine,  risperidone,  chlorpromazine1   May  be  attempted  if  the  patient  has  a  comorbid  condition  that  benefits   from  the  primary  action  of  the  drug1   Agents  that  may  have  sedative  properties  include  gabapentin  and   tiagabine1   Evidence  is  limited1,8   May  be  attempted  if  the  patient  has  a  comorbid  condition  that  benefits   from  the  primary  action  of  the  drug1   Suvorexant  (Belsomra)  is  an  orexin  receptor  antagonist9   Belsomra  approved  for  insomnia  in  2014  and  can  be  used  for  onset  and   maintenance  of  sleep9   Less  cognitive  impairment  and  daytime  drowsiness  than   benzodiazepines  9  

    Key  points  when  using  hypnotics   1. 2. 3. 4. 5. 6. 7.  

         

  Take  on  an  empty  stomach  to  avoid  decreased  absorption  or  delayed  onset.1,3   Avoid  hypnotics  in  pregnant  or  nursing  women  if  possible.1,8   Use  with  caution  in  patients  who  have  compromised  respiratory  function  such  as  COPD  and   sleep  apnea.    Also  avoid  in  patients  who  have  signs  and  symptoms  of  any  depressive   disorder.1,3,8   Use  with  caution  in  elderly  and  reduce  doses.1,2,3   Counsel  patients  to  avoid  ethanol  and  other  CNS  depressants  due  to  additive  effect  with   many  hypnotics.1,3,6   Avoid  in  patients  who  are  under  the  age  of  18  due  to  limited  safety  and  efficacy  data  in  that   population.1,4   Avoid  sudden  or  abrupt  discontinuation  of  benzodiazepines  due  to  risk  of  withdrawal   symptoms.1,2,3,8  

 

Newsletter – March 2015   FDA  Approves  Two  Breakthrough  Vaccinations  for  the  Prevention  of   Serogroup  B  Meningococcal  Disease     Written  by:  Sam  Zohner  –  ISU  Pharm  D  Candidate  2016  

  Within  the  last  six  months,  the  FDA  has  approved  two  meningococcal  vaccinations.    The  difference   between  these  two  vaccines  and  all  other  preceding  meningococcal  vaccines  is  their  coverage  of   serogroup  B.    Before  approval,  current  meningococcal  vaccines  only  covered  serogroups  A,C,Y,  and   W-­‐135.    In  the  US,  serogroups  C  and  Y  account  for  approximately  two-­‐thirds  of  invasive   meningococcal  disease.    Serogroup  B  accounts  for  roughly  one-­‐third.         Meningococcal  disease  in  general  is  most  common  in  those  aged  16-­‐21  years  old.      Bacterial   infection  can  result  in  meningitis  and/or  sepsis.  The  CDC  recommends  that  children  11-­‐12  years  of   age  receive  meningococcal  conjugate  vaccine  and  receive  a  booster  at  age  16.    Furthermore,  the   CDC  advices  those  who  may  be  at  higher  risk,  including  first-­‐year  college  students  living  in   residence  halls,  patients  with  a  damaged  or  removed  spleen,  and  those  traveling  to  or  living  in   countries  in  which  the  disease  is  common,  also  receive  the  vaccine.       The  CDC  has  not  yet  posted  guidelines  for  the  use  of  serogroup  B  meningococcal  vaccines.    Below  is   a  table  summarizing  main  differences  between  the  two  new  meningococcal  vaccines  and  a   commonly  used  tetravalent  conjugate  vaccine.    This  chart  is  not  meant  to  be  comprehensive  nor  in-­‐ depth  and  has  not  been  evaluated  by  the  FDA.  

 

  Trumenba®  

Bexsero®  

Menveo®  

Release  date  10/29/14   Effective  against  serogroup  B  

Release  date  1/23/15   Effective  against  serogroup  B  

Form:  conjugate  vaccine   Approved  for  use  in  ages  10  -­‐ 25  years  in  the  US   Three  dose  series  0,  2,  6   months   0.5ml/dose  IM  suspension   injection,  shake  before  use  

Form:  conjugate  vaccine   Approved  for  use  in  ages  10  -­‐ 25  years  in  the  US   Two  dose  series  0,  1  month  

Most  common  ADR  were  pain   at  the  injection  site  (≥85%),   fatigue  (≥40%),  headache   (≥35%),  muscle  pain  (≥30%),   and  chills  (≥15%)  

Most  common  ADR  were  pain   at  the  injection  site  (≥83%),   myalgia  (≥48%),  erythema   (≥45%),  fatigue  (≥35%),   headache  (≥33%),  induration   (≥28%),  nausea  (≥18%),  and   arthralgia  (≥13%)   Pregnancy  Category  B,  only   animal  studies  

Release  date  2010   Effective  against  serogroups  A,  C,   W-­‐135  and  Y   Form:  conjugate  vaccine   Approved  for  use  in  ages  2   months  -­‐  55  years  in  the  US   Depends,  see  CDC  immunization   schedule   0.5ml/dose  IM  injection,  Two   vials  must  be  combined  before   use   Most  common  ADR  were  pain  at   the  injection  site  (41%),   headache  (30%),  myalgia  (18%),   malaise  (16%)  and  nausea   (10%)  

Pregnancy  Category  B,  only   animal  studies  

0.5ml/dose  IM  suspension   injection,  shake  before  use  

   

Pregnancy  Category  B,  only   animal  studies  

 

 

 

 

Newsletter - March 2015  

References  

  Trimethoprim  -­‐  Sulfamethoxazole  Combined  with  ACE  Inhibitors  or  Angiotensin  Receptor   Blockers  Could  Raise  Risk  of  Sudden  Death  in  Elderly  

   

1.

Juvet  T,  Gourineni  VC,  Ravi  S,  Zarich  SW.    Life-­‐threatening  Hyperkalemia:  A  Potentially  Lethal  Drug   Combination.    Conn  Med.    2013  Sep;77(8):491-­‐3.  PubMed  PMID:  24156179.  

2.

Lederer,  E.  Hyperkalemia.  In  Medscape  (Version  4.0)  [Mobile  application  software].  Updated   periodically.  Accessed  02/28/2015.  

3.

Fralick  M,  Macdonald  EM,  Gomes  T,  Antoniou  T,  Hollands  S,  Mamdani  MM,  Juurlink  DN;  Canadian   Drug  Safety  and  Effectiveness  Research  Network.    Co-­‐trimoxazole  and  Sudden  Death  in  Patients   Receiving  Inhibitors  of  Renin-­‐Angiotensin  System:  Population  Based  Study.    BMJ.  2014  Oct   30;349:g6196.  doi:  10.1136/bmj.g6196.    PubMed  PMID:  25359996.  

4.

Antoniou  T,  Gomes  T,  Juurlink  DN,  Loutfy  MR,  Glazier  RH,  Mamdani  MM.    Trimethoprim-­‐ Sulfamethoxazole-­‐Induced  Hyperkalemia  in  Patients  Receiving  Inhibitors  of  the  Renin-­‐Angiotensin   System:  A  Population-­‐Based  Study.    Arch  Intern  Med.  2010  Jun  28;170(12):1045-­‐9.  doi:   10.1001/archinternmed.2010.142.    PubMed  PMID:  20585070.  

5.

Gentry  CA,  Nguyen  AT.    An  Evaluation  of  Hyperkalemia  and  Serum  Creatinine  Elevation  Associated   with  Different  Dosage  Levels  of  Outpatient  Trimethoprim-­‐Sulfamethoxazole  With  and  Without   Concomitant  Medications.    Ann  Pharmacother.  2013  Dec;47(12):1618-­‐26.  doi:   10.1177/1060028013509973.  Epub  2013  Oct  25.    PubMed  PMID:  24259630.  

6.

Ho  JM,  Juurlink  DN.    Considerations  When  Prescribing  Trimethoprim-­‐Sulfamethoxazole.    CMAJ.  2011   Nov  8;183(16):1851-­‐8.  doi:  10.1503/cmaj.111152.  Epub  2011  Oct  11.    PubMed  PMID:  21989472.  

7.

Lam  N,  Weir  MA,  Juurlink  DN,  Gunraj  N,  Gomes  T,  Mamdani  M,  Hackam  DG,  Jain  AK,  Garg  AX.    Hospital   Admissions  for  Hyperkalemia  With  Trimethoprim-­‐S:  A  Cohort  Study  Using  Health  Care  Database   Codes  for  393,039  Older  Women  With  Urinary  Tract  Infections.    Am  J  Kidney  Dis.  2011   Mar;57(3):521-­‐3.    doi:  10.1053/j.ajkd.2010.11.006.    Epub  2011  Jan  8.    PubMed  PMID:  21216514.  

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Sulfamethoxazole/Trimethoprim.  Micromedex®  Healthcare  Series  [Micromedex  2.0  mobile   application  software].  Greenwood  Village,  CO:  Thomson  Micromedex.  Updated  periodically.  Accessed   02/28/2015.  

 

 

   

     

 

9. Image (page 1) courtesy of office clip art 10. Image (page 2) courtesy of Frompo.com

   

 

Newsletter – March 2015   Hypnotics  and  Insomnia  Refresher   1.

Schutte-­‐Rodin  S;  Broch  L;  Buysse  D;  Dorsey  C;  Sateia  M.  Clinical  guideline  for  the  evaluation  and   management  of  chronic  insomnia  in  adults.  J  Clin  Sleep  Med  2008;4(5):487–504.  

2.

Brunton  L.L,  Chabner  B.A,  Knollmann  B.C.  Chapter  17:  Hypnotics  and  Sedatives.  Goodman  &  Gilman's   The  Pharmacological  Basis  of  Therapeutics.  12th  ed.  New  York:  McGraw-­‐Hill,  2011    

3.

PL  Detail-­‐Document,  Comparison  of  Insomnia  Treatments.  Pharmacist’s  Letter/Prescriber’s  Letter.   July  2014.    

4.

U.S.  Food  and  Drug  Administration.  Dec.  2014.  Sleep  Disorder  (Sedative-­‐Hypnotic)  Drug   Information.    Retrieved  from   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProvides/  

5.

Rosenberg  RP.  Sleep  maintenance  insomnia:  strengths  and  weaknesses  of  current  pharmacologic   therapies.  Ann  Clin  Psychiatry  2006;18:49-­‐56.  

6.

Mayo  Clinic  Staff  (2014)  Prescription  sleeping  pills:  what’s  right  for  you?  In:  Diseases  and  conditions:   insomnia,  Mayo  Clinic.  Retrieved  from  http://www.mayoclinic.org/diseases-­‐conditions/insomnia/  

7.

Kirkwood  CK,  Melton  ST.  Chapter  46.  Insomnia,  Drowsiness,  and  Fatigue.  In:  Krinsky  DL,  Berardi  RR,   Ferrei  S,  et  al,  Eds.  Handbook  of  Nonprescription  Drugs.  17th  ed.  Washington,  DC:  American   Pharmacists  Association,  2012:868-­‐83.  

8.

Arand  DL,  Bonnet  MB  (2014).  Patient  information:  Insomnia  treatments  (Beyond  the  Basics).  In  R.   Benca(Ed.),  UpToDate.  Retrieved  from  http://www.uptodate.com/home/index.html  

9.

Reddy  A,  Puvvada  SC,  Kommisetti  S,  et  al.  Suvorexant:  something  new  for  sleep?  Acta   Neuropsychiatric.  2014  Nov  14:1-­‐3.  

     

     

 

 

10. Image  (page  3)  courtesy  of  LEF.org  

FDA Approves Two Breakthrough Vaccinations for the Prevention of Serogroup B Meningococcal Disease 1.

2.

U.S  Food  and  Drug  Administration.  Nov.  2014.  Trumenba.  Approved  products.  Retrieved  from   http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM421139 .pdf     U.S  Food  and  Drug  Administration.  Jan.  2015.  Bexsero.  Approved  products.  Retrieved  from   http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM431447 .pdf  

  3.

U.S  Food  and  Drug  Administration.  2011.  Menveo.  Approved  products.  Retrieved  from   http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM201349 .pdf  

4.

Centers  for  Disease  Control  and  Prevention  (CDC).  April  2014.  Meningococcal  vaccination.   Meningococcal  disease.  Retrieved  from  http://www.cdc.gov/meningococcal/  

 

March Newsletter.pdf

Hypnotics are drugs used to induce sleep. There are multiple. drug classes that possess the ability to cause hypnosis either as. a secondary or primary action.

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